Name: Predicase
Price: 199 USD

K-number	K070127
Device name	PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
Applicant	Kevin Vu, Dds
Product code	EMN
Device class	Class I
Decision date	Mar 29, 2007
Decision	Substantially Equivalent
Regulation	872.4565

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Source

View the full FDA submission: accessdata.fda.gov

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PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02

Everything you need for a 510(k) submission. Nothing you don't.